Actively Recruiting
A Prospective, Single-Arm, Single-Center Phase II Study Evaluating the Efficacy and Safety of Chidamide Tablets Combined With PD-L1 Inhibitor, Carboplatin, and Etoposide as First-Line Treatment in Patients With Extensive-Stage Small-Cell Lung Cancer (ES-SCLC)
Led by China Medical University, China · Updated on 2026-01-28
36
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment of Chidamide with a PD-L1 inhibitor, carboplatin, and etoposide as a first-line therapy for patients with extensive-stage small-cell lung cancer (ES-SCLC). This Phase II, single-arm study aims to assess how this combination affects progression-free survival and other outcomes such as response rates and overall survival. The study is sponsored by China Medical University, China. Approximately 36 participants will receive an induction therapy consisting of Chidamide (15 mg orally on specific days in a 21-day cycle for 4 cycles) combined with a PD-L1 inhibitor, carboplatin, and etoposide following their standard dosing guidelines. After induction, participants will continue with maintenance therapy using Chidamide (20 mg orally twice weekly) and the PD-L1 inhibitor until disease progression, unacceptable side effects, withdrawal, or study end. Participants will be closely monitored during the study through assessments of tumor response using RECIST v1.1 criteria from baseline up to around 24 months. Safety and tolerability will also be tracked by recording any treatment-related side effects. The study includes regular evaluations and follow-ups to measure progression-free survival, objective response rate, disease control rate, duration of response, and overall survival over this period.
CONDITIONS
Brief Title
A Prospective, Single-Arm, Single-Center Phase II Study Evaluating the Efficacy and Safety of Chidamide Combined With PD-L1 Inhibitor, Carboplatin, and Etoposide as First-Line Treatment in Patients With Extensive-Stage Small-Cell Lung Cancer (ES-SCLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Histologically confirmed extensive-stage small-cell lung cancer not suitable for local radical therapy
- No prior systemic therapy for extensive-stage small-cell lung cancer
- ECOG performance status of 0 or 1
- At least one measurable lesion according to RECIST v1.1
- Expected survival of at least 3 months
- Adequate function of blood, liver, kidneys, and heart
- Use of effective contraception from consent until 180 days after last dose
- For active hepatitis B infection, HBV DNA less than 2000 IU/mL within 28 days before treatment and stable antiviral therapy
- Recovery from previous treatment side effects to Grade 1 or less (except hair loss)
- Signed informed consent form
You will not qualify if you...
- Conditions significantly affecting oral drug absorption
- Prior treatment with HDAC inhibitors or immune checkpoint inhibitors
- Known allergy to any component of the study drugs
- Other cancers within past 5 years except certain cured types
- Participation in another clinical trial within 4 weeks
- Immunodeficiency, HIV infection, or organ transplantation history
- Uncontrolled heart disease or QTc interval over 450 ms
- Pregnancy, breastfeeding, or unwillingness to use effective contraception
- Severe other medical conditions deemed unsafe by the investigator
- History of neurological or psychiatric disorders
- Any condition making participation unsuitable according to the investigator's judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Variable duration including 4 induction cycles of 21 days each and maintenance until disease progression or discontinuation
Participants receive Chidamide tablets combined with a PD-L1 inhibitor, Carboplatin, and Etoposide as first-line treatment for extensive-stage small-cell lung cancer. The induction phase includes Chidamide 15 mg on specific days of each 21-day cycle for 4 cycles along with PD-L1 inhibitor, Carboplatin, and Etoposide according to prescribing information. This is followed by a maintenance phase with Chidamide 20 mg twice weekly until disease progression or other stopping criteria.
Visits as per treatment cycles and drug administration schedules
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Actively Recruiting
Research Team
Y
Yunpeng Liu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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